Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

Active, not recruiting

• Conditions: Colorectal Neoplasm

• Registration Number: NCT03936530
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

Brief Summary

The infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. The aim of this study is to assess the rate of this lymph node metastasis and to reveal its prognostic value for colon cancer located at hepatic flexure and right half of transverse colon. Meanwhile, we can evaluate the safety and feasibility of this extented lymphadenectomy in right hemi-colectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-10-20
• Primary Completion: 2023-08-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

• Age between 18 and 75 years
• American Society of Anesthesiologists (ASA) score I to III
• A biopsy proven histological diagnosis of colorectal carcinoma
• tumor located at hepatic flexure and right half of transverse colon
• Undergoing right hemi-colectomy with extented lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
• Preoperative staging cT2-4aN0M0 or cTanyN+M0
• Willing to participate and informed consent signed

Exclusion Criteria

• Pregnant or lactating women
• Synchronous colorectal carcinoma
• History of colorectal cancer or other malignant tumors
• Clinical evidence of metastasis
• Preoperative staging cT1N0 or cT4bNany
• Emergency procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
metastasis rate	an average of 1 year	metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node

Secondary Outcome Measures

Name	Time	Method
intraoperative complication	an average of 1 year	intraoperative complication
postoperative complication	an average of 1 year	postoperative complication
lymphadenectomy time	an average of 1 year	time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
3-year DFS	an average of 3 years	3-year disease free survival

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, Shanghai, China